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The primary objective of the proposed pilot study is to seek to compare the efficacy of two brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for improving depressive symptoms, functioning, and quality of life (QOL). The treatments will consist of four sessions, which will be delivered during hospitalization.
First Visit (after Identification by PHQ Intake Score): If, after being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the subject will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions. These sessions will be provided subsequently by an attending psychiatrist or health psychologist in Psychiatry (currently Drs. IsHak, Danovitch, Hedrick, Chaudhry, and Sumner).
Study Visits #'s 2 - 5: Details about the four therapy sessions are listed below. Study Participants will participate in therapy in the hospital room, with no other staff or patients present. Family and friends will not be allowed to be present. If nurses need to enter the room during the therapy session, therapy will be temporarily suspended. The treating clinician will choose a time for therapy that minimizes interruption by examining the patient's schedule and consulting with the attending psychiatrist.
At the end of Visit #5, the study participant will also be offered a referral, by the attending psychiatrist or health psychologist, to a community-based therapist who is not affiliated with CSMC, and if the subject decides to participate, to continue therapy after discharge. The community-based therapist may or may not utilize the same approach utilized during the study. Community-based therapists will be selected among those who are known in the community to the treating psychiatrist/health psychologist, for whom the treating psychiatrist/psychologist can personally vouch. The treating psychiatrist/psychologist may select a community-based therapist whom the patient can afford, or is covered by the patient's insurance. Study participants and therapist will work together to select a community-based provider for use after discharge. The community-based therapy is not part of the research study and, therefore, subjects will be told that seeking this additional therapy is up to the subject and any potential costs related to these sessions will be covered by the subject and/or their insurance company. In the event of early discharge based on medical reasons, the therapy will be concluded and the patient will be referred to the community-based therapist. This will be considered an incomplete delivery of the sessions (early withdrawal).
Treatments Both treatments will consist of four sessions during inpatient hospitalization.
Cognitive Behavioral Therapy (CBT)
Behavioral Activation for Medical Inpatients with Depression (BAMID or BA)
Study Visit #6 - Discharge: Before discharge, participants will complete three questionnaires administered by study staff, as follows: 1) a paper version of the PHQ-9 depression inventory, to assess depressive symptoms; 2) the National Institute of Health Patient Reported Outcome Measurement Information System (NIH PROMIS) 10-item Global Health scale, to assess QOL (PROMIS-10); and 3) the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, to assess functioning. These measures will serve as a baseline for comparison with data obtained 90 days later. Participants will also be asked whether they agree to be contacted in 90 days for follow-up assessment; those who agree will be contacted by study staff for Visit #7.
Study Visit #7 - After Discharge: 90 days after the study participant is discharged from the hospital, study staff will contact the subject by phone to inquire about whether they utilized the referral to community-based therapy or not; those who did use the referral will be asked the number of sessions completed over the last 90 days, and the frequency of those sessions. In addition, study staff will also ask whether the subject started antidepressant medication after they left the hospital. If so, they will be asked what the medication and dosage was and how much of the medication they took and (assuming a 30-day dosage), how many pills they have left from the current bottle and when this bottle was prescribed. Any mental health issues that arise during this phone call will be referred to the original attending psychiatrist, or to the community-based therapist if the study participant chose to utilize the referral. Next, the staff member will ask if the study participant is interested in completing study measures over the phone, or on paper. If the subject agrees, the study staff member will administer the same three questionnaires given before discharge over the phone, taking approximately 30 minutes. If the subject prefers to complete these on paper, questionnaires will be mailed by US postal mail along with a self-addressed stamped envelope, and the phone call will end after 5 minutes. These data will be collected and de-identified for analysis.
4 Anticipated Level of Risk:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy | Experimental | The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive factors and behavioral factors on affective distress. |
|
| Behavioral Activation | Experimental | Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive factors | Behavioral | The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptom Severity | The PHQ-9 is used to measure depressive symptoms | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functioning | WHODAS is used to measure functioning | 12 weeks |
| Overall Health and Quality of life (QOL) | NIH-PROMIS-10 is used to measure the overall health and QOL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waguih W IsHak, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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After being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the patient will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions.
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| Behavioral factors | Behavioral | The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress. |
|
| Increase engagement of pleasant events | Behavioral | Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events. |
|
| 12 weeks |